Muscular FatigueNCT05217433
Oleuropein and Muscle Energy Metabolism
A study testing Olive leaf extract in people with Muscular Fatigue, run by Société des Produits Nestlé (SPN) at 1 site in Netherlands.
Trial summary
Preclinical studies performed at Nestlé Research (NR) identified oleuropein as a novel activator of mitochondrial calcium import. This potentiated mitochondrial calcium uptake resulted in decreased phosphorylation of the enzyme pyruvate dehydrogenase (PDH), which is linked to its activation as a rate limiting enzyme… Read more about this study
- Who is it for?
- Ages 50 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscular Fatigue
- What is being tested?
- Olive leaf extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Nov 2021to 10 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- 50 to 70 years old
- BMI 18.5-29.9 kg/m2
- Healthy as per medical history and investigator's/ physician's judgement
- Having given informed consent
Who cannot join
- Allergy/intolerance to the study product
- >5% body mass change in the previous 3 months
- HbA1c ≥ 6.5%
- Blood pressure >140/90 mmHg
- Participating in a structured (progressive) exercise program
- Smoking
Show all 16Show fewer
- Diagnosed acute or chronic medical conditions that, in the opinion of the investigator, could impact study outcomes
- Diagnosed musculoskeletal disorders
- Chronic use of gastric acid suppressing medication
- Unauthorized concomitant medications such as calcium antagonists (e.g. valproate), oral corticosteroids, anything that will prevent subjects from safely completing the study according to the investigator or medications / drugs known interfering with the expected mechanism of action of IP or to affect the outcome parameters
- Alcohol (intake higher than 3 servings per day. One serving is 0.4 dl of alcohol, 1 dl of wine, or 3 dl of beer) or drug abuse
- Overly imbalanced or restrictive diet (e.g. hyperproteic, vegan, ketogenic, etc.)
- Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol
- Any implants that would be a contra-indication for performing an MRI scan.
- Participation in another study at the same time
- Blood donation in the past 2 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy of Oleuropein on Skeletal Muscle Energy Metabolism and Fatigue in Humans
Preclinical studies performed at Nestlé Research (NR) identified oleuropein as a novel activator of mitochondrial calcium import. This potentiated mitochondrial calcium uptake resulted in decreased phosphorylation of the enzyme pyruvate dehydrogenase (PDH), which is linked to its activation as a rate limiting enzyme for mitochondrial oxidation, as well as increasing mitochondrial oxygen consumption, resulting ultimately in decreases in muscle fatigue. In addition, NR demonstrated that during aging, mitochondrial calcium and oxygen consumption rates are decreased in isolated skeletal muscle fibers. The next step in the evidence development is to demonstrate efficacy of oleuropein for improved muscle energy and decreased physical fatigue in a healthy aging population.
- Conditions
- Muscular Fatigue
- Being tested
- Olive leaf extract, Placebo
- Keywords
- Skeletal muscle energy and fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olive leaf extractOther
The investigational product is a capsule containing 100mg of the active ingredient oleuropein and will be provided once daily in the form of a 250mg olive leaf extract (i.e. 100mg of oleuropein per day) product for the duration of the intervention period (36 days).
PlaceboOther
The control will be a placebo capsule containing 336 mg of cellulose microcrystalline, matching the investigational product appearance.
| Study group | Role | What they receive |
|---|---|---|
| Investigational product | Experimental | The investigational product is a capsule containing 100mg of the active ingredient oleuropein and will be provided once daily in the form of a 250mg olive leaf extract (i.e. 100mg of oleuropein per day) product for the duration of the intervention period (36 days). Receives: Other: Olive leaf extract |
| Control arm | Placebo comparator | The control will be a placebo capsule containing 336 mg of cellulose microcrystalline, matching the investigational product appearance. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploratory outcomes - Evaluate the changes in Pyruvate dehydrogenase activation between oleuropein and placebo groups following 1 single dose
measured by western blotting
Measured: Chronic effect after 36 days of intake
Exploratory outcomes - Evaluate the changes in Pyruvate dehydrogenase activation between oleuropein and placebo groups following 1 single dose
measured by biochemical assay analysis
Measured: Acute effect after first product intake + chronic effect after 36 days of intake
Exploratory outcomes - to evaluate the changes Mitocondrial respiration between oleuropein and placebo groups following 1 single dose
measured the rates of oxygen consumption (respiration or JO2) using Oroboros Oxygraph 2K systems with physiological ADP concentrations using permeabilized muscle fibres.
Measured: Acute effect after first product intake + chronic effect after 36 days of intake
Exploratory outcomes- to evaluate the changes of fatigue between oleuropein and placebo groups following 1 single dose
measured using Biodex dynamometer
Measured: After 4 weeks of supplementation
Exploratory outcomes - to evaluate the changes of fatigue between oleuropein and placebo groups
measured using Biodex dynamometer
Measured: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes of Pyruvate dehydrogenase activation between oleuropein and placebo groups
measured by western blotting
Measured: Chronic effect (after 36 days of supplementation)
Exploratory outcomes - to evaluate the changes of Pyruvate dehydrogenase activation between oleuropein and placebo groups
measured by biochemical assay analysis
Measured: Chronic effect (after 36 days of supplementation)
Exploratory outcomes - To evaluate the changes of Mitochondrial respiration between oleuropein and placebo groups
measured the rates of oxygen consumption (respiration or JO2) using Oroboros Oxygraph 2K systems with physiological ADP concentrations using permeabilized muscle fibres.
Measured: Chronic effect (after 36 days of supplementation)
Secondary outcomes (24)
Exploratory outcomes - to evaluate the changes of whole body respiratory exchange ratio (RER) between oleuropein and placebo groups following 1 single dose
measured the oxygen and carbon dioxide volume using indirect calorimetry with ventilated hood
Measured: Acute effect after first product intake+ chronic effect after 36 days of intake
Exploratory outcomes - to evaluate the changes of oleuropein metabolites between oleuropein and placebo groups following 1 single dose
measured by the analyze of oleuropein metabolites in blood
Measured: Acute effect after first product intake + chronic effect after 36 days of intake
Exploratory outcomes - to evaluate the changes of glucose concentration between oleuropein and placebo groups following 1 single dose
measured by the analyze glucose in blood
Measured: Acute effect after first product intake + chronic effect after 36 days of intake
Exploratory outcomes - to evaluate the changes Blood glucose, insulin, free fatty acid concentrations -between oleuropein and placebo groups following 1 single dose
measured by the analyze of Insulin in blood
Measured: Acute effect after first product intake + chronic effect after 36 days of intake
Exploratory outcomes - to evaluate the changes of free fatty acid concentration between oleuropein and placebo groups following 1 single dose
measured by the analyze of free fatty acid concentration (FFA, TG) in blood
Measured: Acute effect after first product intake + chronic effect after 36 days of intake
Exploratory outcomes - to evaluate the changes of blood pressure between oleuropein and placebo groups following 1 single dose
measured using automated inflatable cuff
Measured: Acute effect after first product intake + chronic effect after 36 days of intake
Exploratory outcomes - to evaluate the changes of anti-inflammatory markers between oleuropein and placebo groups
measured by the analyze of anti-inflammatory markers in blood
Measured: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes of Antioxidant markers between oleuropein and placebo groups
measured by the analyze of antioxidant markers in blood
Measured: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes in glucose concentration between oleuropein and placebo groups
measured by the analyze glucose in blood
Measured: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes of insulin concentration between oleuropein and placebo groups
measured by the analyze of insulin in blood
Measured: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes of free fatty acid concentration between oleuropein and placebo groups
measured by the analyze of free fatty acid concentration (FFA, TG) in blood
Measured: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes in Mood state and quality of life between oleuropein and placebo groups
measured with the World Health Organisation quality of life questionnaire (WHOQOL-BREF) (rating 0 for 'not at all' and 5 for 'an extreme amount')
Measured: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes in Mood state and quality of life between oleuropein and placebo groups
measured with the Profile of Mood States - short-form (POMS-SF) - scale (rating 0 for 'not at all' and 4 for 'extremely')
Measured: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes in Mood state and quality of life between oleuropein and placebo groups
measured with the Quality of Life (QoL) questionnaires
Measured: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes in the fatigue perception and mood state pre/post Biodex measurement between oleuropein and placebo groups
measured with the current mood questionnaire (rating 0 for 'not at all' - 4 for 'extremely')
Measured: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes in the fatigue perception and mood state pre/post Biodex measurement between oleuropein and placebo groups
RPE visual analog scale Questionnaire - BORG scale (6 for 'no exertion - 20 for 'maximal exertion'
Measured: Chronic effect (after 29 days of supplementation)
Exploratory outcomes to evaluate the changes in body composition between oleuropein and placebo groups
measure the whole body muscle and fat content using Magnetic resonance imaging (MRI)
Measured: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - Whole body respiratory exchange ratio - To evaluate the changes of Whole body respiratory exchange ratio (RER) between oleuropein and placebo groups
measure the oxygen and dioxygen volume using Indirect calorimetry with ventilation hood
Measured: Chronic effect (after 36 days of supplementation)
Exploratory outcomes - To evaluate the changes of oleuropein metabolites between oleuropein and placebo groups
measure by analyzing Oleuropein metabolites in blood
Measured: Chronic effect (after 36 days of supplementation)
Exploratory outcomes - to evaluate the changes of molecular signalling, and protein and mRNA levels of regulators of muscle metabolism between oleuropein and placebo groups
measured by analyzing RNAseq and MS-based proteomics
Measured: Chronic effect (after 36 days of supplementation)
Exploratory outcomes - to evaluate the changes of molecular signalling, and protein and mRNA levels of regulators oleuropein and placebo groups
measured using Western Blot
Measured: Chronic effect (after 36 days of supplementation)
Exploratory outcomes - to evaluate the changes of molecular signalling, and protein and mRNA levels of regulators oleuropein and placebo groups
measured by analyzing polymerase chain reaction
Measured: Chronic effect (after 36 days of supplementation)
Exploratory outcomes - to evaluate the changes in Strength between oleuropein and placebo groups
measured using biodex dynanometer
Measured: After 4 weeks of supplementation
Exploratory outcomes to evaluate the changes of strenght between oleuropein
measured using biodex dynanometer
Measured: Chronic effect (after 29 days of supplementation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start4 Nov 2021
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscular FatigueStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-centre, double-blind, placebo controlled, randomised 2-arms parallel group study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maastricht University Medical Center
- Responsible party
- Sponsor
- Investigators
- Luc van Loon, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217433
- Sponsor's protocol ID
- 20.22.NRC
- Status last verified
- Mar 2023
- First submitted
- 25 Nov 2021
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pinckaers PJ, Petrick HL, Horstman AM, Moreno-Asso A, De Marchi U, Hendriks FK, Kuin LM, Fuchs CJ, Grathwohl D, Verdijk LB, Zorenc AH, Senden JM, Migliavacca E, Metairon S, Poquet L, Morin-Rivron D, Karagounis LG, Holloway GP, Feige JN, van Loon LJ. Oleuropein Supplementation Increases Resting Skeletal Muscle Fractional Pyruvate Dehydrogenase Activity but Does Not Influence Whole-Body Metabolism: A Randomized, Double-Blind, and Placebo-Controlled Trial in Healthy, Older Males. J Nutr. 2025 May;155(5):1373-1386. doi: 10.1016/j.tjnut.2025.02.015. Epub 2025 Feb 22.
PubMed 39993475
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Study to Investigate the Efficacy of Oleuropein on Skeletal Muscle Energy Metabolism and Fatigue in Humans
- ClinicalTrials.gov ID
- NCT05217433
- Acronym / sponsor ID
- 20.22.NRC
- Conditions
- Muscular Fatigue
- Keywords
- Skeletal muscle energy and fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Maastricht University Medical Center
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preclinical studies performed at Nestlé Research (NR) identified oleuropein as a novel activator of mitochondrial calcium import. This potentiated mitochondrial calcium uptake resulted in decreased phosphorylation of the enzyme pyruvate dehydrogenase (PDH), which is linked to its activation as a rate limiting enzyme for mitochondrial oxidation, as well as increasing mitochondrial oxygen consumption, resulting ultimately in decreases in muscle fatigue. In addition, NR demonstrated that during aging, mitochondrial calcium and oxygen consumption rates are decreased in isolated skeletal muscle fibers. The next step in the evidence development is to demonstrate efficacy of oleuropein for improved muscle energy and decreased physical fatigue in a healthy aging population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-centre, double-blind, placebo controlled, randomised 2-arms parallel group study.
| Arm | Type | Receives |
|---|---|---|
| Investigational product | Experimental | Other: Olive leaf extractThe investigational product is a capsule containing 100mg of the active ingredient oleuropein and will be provided once daily in the form of a 250mg olive leaf extract (i.e. 100mg of oleuropein per day) product for the duration of the intervention period (36 days). |
| Control arm | Placebo comparator | Other: PlaceboThe control will be a placebo capsule containing 336 mg of cellulose microcrystalline, matching the investigational product appearance. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male
- 50 to 70 years old
- BMI 18.5-29.9 kg/m2
- Healthy as per medical history and investigator's/ physician's judgement
- Having given informed consent
Key exclusion criteria (16 listed)
- Allergy/intolerance to the study product
- >5% body mass change in the previous 3 months
- HbA1c ≥ 6.5%
- Blood pressure >140/90 mmHg
- Participating in a structured (progressive) exercise program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olive leaf extractThe investigational product is a capsule containing 100mg of the active ingredient oleuropein and will be provided once daily in the form of a 250mg olive leaf extract (i.e. 100mg of oleuropein per day) product for the duration of the intervention period (36 days). | Other | Investigational product |
| PlaceboThe control will be a placebo capsule containing 336 mg of cellulose microcrystalline, matching the investigational product appearance. | Other | Control arm |
Primary outcome
Exploratory outcomes - Evaluate the changes in Pyruvate dehydrogenase activation between oleuropein and placebo groups following 1 single dose
Time frame: Chronic effect after 36 days of intake
measured by western blotting
Exploratory outcomes - Evaluate the changes in Pyruvate dehydrogenase activation between oleuropein and placebo groups following 1 single dose
Time frame: Acute effect after first product intake + chronic effect after 36 days of intake
measured by biochemical assay analysis
Exploratory outcomes - to evaluate the changes Mitocondrial respiration between oleuropein and placebo groups following 1 single dose
Time frame: Acute effect after first product intake + chronic effect after 36 days of intake
measured the rates of oxygen consumption (respiration or JO2) using Oroboros Oxygraph 2K systems with physiological ADP concentrations using permeabilized muscle fibres.
Exploratory outcomes- to evaluate the changes of fatigue between oleuropein and placebo groups following 1 single dose
Time frame: After 4 weeks of supplementation
measured using Biodex dynamometer
Exploratory outcomes - to evaluate the changes of fatigue between oleuropein and placebo groups
Time frame: Chronic effect (after 29 days of supplementation)
measured using Biodex dynamometer
Exploratory outcomes - to evaluate the changes of Pyruvate dehydrogenase activation between oleuropein and placebo groups
Time frame: Chronic effect (after 36 days of supplementation)
measured by western blotting
Exploratory outcomes - to evaluate the changes of Pyruvate dehydrogenase activation between oleuropein and placebo groups
Time frame: Chronic effect (after 36 days of supplementation)
measured by biochemical assay analysis
Exploratory outcomes - To evaluate the changes of Mitochondrial respiration between oleuropein and placebo groups
Time frame: Chronic effect (after 36 days of supplementation)
measured the rates of oxygen consumption (respiration or JO2) using Oroboros Oxygraph 2K systems with physiological ADP concentrations using permeabilized muscle fibres.
24 secondary outcomes
Exploratory outcomes - to evaluate the changes of whole body respiratory exchange ratio (RER) between oleuropein and placebo groups following 1 single dose
Time frame: Acute effect after first product intake+ chronic effect after 36 days of intake
Exploratory outcomes - to evaluate the changes of oleuropein metabolites between oleuropein and placebo groups following 1 single dose
Time frame: Acute effect after first product intake + chronic effect after 36 days of intake
Exploratory outcomes - to evaluate the changes of glucose concentration between oleuropein and placebo groups following 1 single dose
Time frame: Acute effect after first product intake + chronic effect after 36 days of intake
Exploratory outcomes - to evaluate the changes Blood glucose, insulin, free fatty acid concentrations -between oleuropein and placebo groups following 1 single dose
Time frame: Acute effect after first product intake + chronic effect after 36 days of intake
Exploratory outcomes - to evaluate the changes of free fatty acid concentration between oleuropein and placebo groups following 1 single dose
Time frame: Acute effect after first product intake + chronic effect after 36 days of intake
Exploratory outcomes - to evaluate the changes of blood pressure between oleuropein and placebo groups following 1 single dose
Time frame: Acute effect after first product intake + chronic effect after 36 days of intake
Exploratory outcomes - to evaluate the changes of anti-inflammatory markers between oleuropein and placebo groups
Time frame: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes of Antioxidant markers between oleuropein and placebo groups
Time frame: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes in glucose concentration between oleuropein and placebo groups
Time frame: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes of insulin concentration between oleuropein and placebo groups
Time frame: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes of free fatty acid concentration between oleuropein and placebo groups
Time frame: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes in Mood state and quality of life between oleuropein and placebo groups
Time frame: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes in Mood state and quality of life between oleuropein and placebo groups
Time frame: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes in Mood state and quality of life between oleuropein and placebo groups
Time frame: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes in the fatigue perception and mood state pre/post Biodex measurement between oleuropein and placebo groups
Time frame: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - to evaluate the changes in the fatigue perception and mood state pre/post Biodex measurement between oleuropein and placebo groups
Time frame: Chronic effect (after 29 days of supplementation)
Exploratory outcomes to evaluate the changes in body composition between oleuropein and placebo groups
Time frame: Chronic effect (after 29 days of supplementation)
Exploratory outcomes - Whole body respiratory exchange ratio - To evaluate the changes of Whole body respiratory exchange ratio (RER) between oleuropein and placebo groups
Time frame: Chronic effect (after 36 days of supplementation)
Exploratory outcomes - To evaluate the changes of oleuropein metabolites between oleuropein and placebo groups
Time frame: Chronic effect (after 36 days of supplementation)
Exploratory outcomes - to evaluate the changes of molecular signalling, and protein and mRNA levels of regulators of muscle metabolism between oleuropein and placebo groups
Time frame: Chronic effect (after 36 days of supplementation)
Exploratory outcomes - to evaluate the changes of molecular signalling, and protein and mRNA levels of regulators oleuropein and placebo groups
Time frame: Chronic effect (after 36 days of supplementation)
Exploratory outcomes - to evaluate the changes of molecular signalling, and protein and mRNA levels of regulators oleuropein and placebo groups
Time frame: Chronic effect (after 36 days of supplementation)
Exploratory outcomes - to evaluate the changes in Strength between oleuropein and placebo groups
Time frame: After 4 weeks of supplementation
Exploratory outcomes to evaluate the changes of strenght between oleuropein
Time frame: Chronic effect (after 29 days of supplementation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Derived from this study: PubMed 39993475Pinckaers PJ, Petrick HL, Horstman AM, Moreno-Asso A, De Marchi U, Hendriks FK, Kuin LM, Fuchs CJ, Grathwohl D, Verdijk LB, Zorenc AH, Senden JM, Migliavacca E, Metairon S, Poquet L, Morin-Rivron D, Karagounis LG, Holloway GP, Feige JN, van Loon LJ. Oleuropein Supplementation Increases Resting Skeletal Muscle Fractional Pyruvate Dehydrogenase Activity but Does Not Influence Whole-Body Metabolism: A Randomized, Double-Blind, and Placebo-Controlled Trial in Healthy, Older Males. J Nutr. 2025 May;155(5):1373-1386. doi: 10.1016/j.tjnut.2025.02.015. Epub 2025 Feb 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc van Loon principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olive leaf extract in people with Muscular Fatigue, run by Société des Produits Nestlé (SPN) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exploratory outcomes - Evaluate the changes in Pyruvate dehydrogenase activation between oleuropein and placebo groups following 1 single dose (time frame: Chronic effect after 36 days of intake). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05217433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.